AstraZeneca drug a breakthrough therapy for bladder cancer

FDA has granted breakthrough therapy designation for durvalumab (MEDI4736, AstraZeneca) for the treatment of urothelial bladder cancer.

The experimental drug is being investigated for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based therapy.

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Durvalumab is a human monoclonal antibody that works by targeting a protein known as programmed death ligand-1 (PD-L1), which is thought to play a role in the suppression of the immune system. By blocking the interaction of PD-L1 and its receptor, durvalumab works to help prevent suppression of the immune system and allow the body to attack the cancer.

Urothelial bladder cancer is a cancer that begins in the epithelial layer of the bladder as opposed to other areas of the urinary tract, such as the urethra, ureters, or prostate.  It is the ninth most common form of cancer worldwide and metastatic bladder cancer still has a dismal 5-year survival rate of less than 15%.

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Durvalumab was granted breakthrough therapy designation based on early clinical data from a phase 1 study in patients with advanced metastatic urothelial bladder cancer. The results of the study have not been released, but have been submitted for presentation at a future medical meeting.

Durvalumab is also being studied in a clinical trial program as monotherapy and in combination with other therapies for treatment of non-small cell lung cancer (NSCLC), head and neck, bladder, gastric, pancreatic, hepatocellular carcinoma (HCC) and blood cancers. 

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